2018 -- S 2535

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LC004814

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2018

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - PRESCRIPTION DRUG SALES -

REPRESENTATIVE DISCLOSURE ACT

     

     Introduced By: Senators Miller, Goldin, Calkin, Satchell, and Raptakis

     Date Introduced: March 01, 2018

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Legislative findings and declaration of purpose. The general assembly

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hereby finds and declares that:

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     (1) Containing health care costs requires containing prescription drug costs. The

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costs of prescription drugs have been increasing dramatically. In order to contain prescription

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drug costs, it is essential to understand the drivers of those costs, including increases in

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prescriptions and changes in prescription patterns from low-cost to high-cost drugs.

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     (2) Drug companies employ pharmaceutical sales representatives to increase sales by

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persuading providers of health care to prescribe certain drugs. Sales representatives may

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provide education to the provider of health care, but often also include inducements in the

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form of gifts and drug samples.

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     (3) Drug sales representatives often have access to physician prescription tracking

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data.

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     (4) The state has an interest in requiring disclosures and regulating the practice of

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drug sales representatives.

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     SECTION 2. Title 5 of the General Laws entitled "BUSINESSES AND PROFESSIONS"

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is hereby amended by adding thereto the following chapter:

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CHAPTER 19.3

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THE PRESCRIPTION DRUG SALES REPRESENTATIVE DISCLOSURE ACT

 

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     5-19.3-1. Short title.

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     This chapter shall be known and may be cited as the "The Prescription Drug Sales

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Representative Disclosure Act."

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     5-19.3-2. Definitions.

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     As used in this chapter, the following words and terms shall have the following meaning:

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     (1) "Department" means the department of business regulation.

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     (2) "Director" means the director of the department of business regulation or their

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designee.

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     (3) "Manufacturer" means a pharmaceutical, biological product, or medical device

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manufacturer or any other person who is engaged in the production, preparation, propagation,

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compounding, processing, marketing, packaging, repacking, distributing, or labeling of

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prescribed products. The term does not include a wholesale distributor of biological products, a

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retailer, or a pharmacist. The term also does not include a manufacturer whose only prescribed

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products are classified as Class I by the U.S. Food and Drug Administration, are exempt from

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pre-market notification under § 510(k) (21 U.S.C. 360 § 510 (k)) of the Federal Food, Drug and

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Cosmetic Act, and are sold over the counter without a prescription.

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     (4) "Medical facility" means any freestanding emergency-care facility, health care

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facility, physician or podiatry ambulatory-surgery center, or other similar entity licensed by the

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state.

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     (5) "Pharmaceutical sales representative" means a person who markets prescription drugs

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to providers of health care licensed, certified or registered in this state, pharmacies or employees

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thereof, operators or employees of medical facilities or persons licensed or certified by the state.

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     (6) "Prescription drug" means a drug as defined in 21 U.S.C. § 321.

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     (7) "Provider of health care" means any person licensed in this state to administer or

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prescribe a prescription drug.

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     5-19.3-3. Pharmaceutical manufacturer and sales representative registration,

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disclosure, and transparency report.

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     (a) A manufacturer of a prescription drug shall provide to the department a list of each

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pharmaceutical sales representative who markets prescription drugs on behalf of the manufacturer

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to providers of health care in this state, pharmacies or employees thereof, or operators or

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employees of medical facilities or persons licensed in this state.

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     (1) The manufacturer shall inform the department by any means acceptable to the

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department of a change in the manufacturer's list within thirty (30) days of the change. Failure to

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timely inform the department of a change may result in a penalty to be determined by the

 

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department.

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     (2) The manufacturer shall refile or update the list annually.

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     (b) The department shall provide electronic access to the most recent list provided by

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each manufacturer pursuant to subsection (a) of this section to each provider of health care

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licensed, certified or registered in this state, operator of a pharmacy, and operator of a medical

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facility, or person licensed or certified under the provisions of title 5 for the purposes of ensuring

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compliance with the requirements of subsection (c) of this section. The department shall also

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provide electronic access to the information to the department of health and public access via the

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department's website. This subsection must not be construed to impose any duty on a provider of

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health care, operator of a pharmacy, or operator of a medical facility or person licensed or

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certified under the provisions of title 5 to ensure such compliance.

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     (c) A person who is not included on a current list submitted pursuant to subsection (a) of

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this section shall not market prescription drugs on behalf of a manufacturer to any provider of

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health care licensed, certified or registered in this state, pharmacy or employee thereof, operator

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or employee of a medical facility or person licensed or certified under the provisions of title 5.

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     (d) On or before March 1 of each year, each person who was included on a list of

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pharmaceutical sales representatives submitted pursuant to subsection (a) of this section at any

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time during the immediately preceding calendar year shall submit to the department a report,

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which must include, for the immediately preceding calendar year:

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     (1) A list of providers of health care, pharmacies and employees thereof, and operators

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and employees of medical facilities and persons licensed or certified under the provisions of title

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5 to whom the pharmaceutical sales representative provided:

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     (i) Any type of compensation, gift, or thing of value, with a value that exceeds ten dollars

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($10.00); or

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     (ii) Total compensation, gift, or thing of value, with a value that exceeds one hundred

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dollars ($100) in aggregate; and

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     (2) The name and manufacturer of each prescription drug for which the pharmaceutical

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sales representative provided a free sample to a provider of health care licensed, certified or

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registered in this state, pharmacy or employee thereof, or operator or employee of a medical

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facility or person licensed or certified under the provisions of title 5.

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     (e) The department shall analyze annually the information submitted pursuant to

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subsection (d) of this section and compile a report on the activities of pharmaceutical sales

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representatives in this state. On or before June 1 of each year, the department shall:

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     (i) Post the report on the website maintained by the department; and

 

LC004814 - Page 3 of 5

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     (ii) Submit the report to the governor, the director of the department of health, the

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commissioner of the office of health insurance, the speaker of the house and the senate president.

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     5-19.3-4. Fees and penalties.

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     (a) A fee in the amount of fifty-five dollars ($55.00) annually shall be charged by the

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director from each manufacturer, per each pharmaceutical sales representative listed by the

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manufacturer. All revenue collected pursuant to this chapter shall be deposited as restricted

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receipts available to the department as described in § 42-14-9.

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     (b) The attorney general may bring an action in the civil division of the superior court,

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Providence County for injunctive relief, costs, and attorneys' fees, and to impose, on a

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manufacturer that fails to provide the information required by this chapter, a civil penalty of no

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more than ten thousand dollars ($10,000) per violation. Each unlawful failure to provide

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information shall constitute a separate violation. In any action brought pursuant to this section,

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the attorney general shall have the same authority to investigate and to obtain remedies as if the

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action were brought under the deceptive trade practices act, chapter 13.1 of title 6.

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     SECTION 3. This act shall take effect on January 1, 2019.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - PRESCRIPTION DRUG SALES -

REPRESENTATIVE DISCLOSURE ACT

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     This act would require prescription drug manufacturers to file a detailed, updated list of

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each pharmaceutical sales representative and to pay an annual fee for each name listed with the

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department of business regulation. Failure to comply would result in civil penalties.

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     This act would take effect on January 1, 2019.

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